# LZY: Prosthesis, Hip, Hemi-, Femoral, Metal Ball

- Device class: 2; regulation: 21 CFR 888.3360; FDA's rule: 510(k) required
- FDA decisions: 8
- 510(k) review time 2021–2025: median 62 days (middle half 62–62)
- Recalls: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026; MAUDE to Sep 30, 2026

## Decisions per year (last 10)
- 1989: 1
- 1990: 2
- 1992: 1
- 1993: 1
- 1998: 1
- 2011: 1
- 2023: 1

## Most-cited predicates
- K896580: Uni-Polar Head (1990), cited by 8
- K903084: Modular Cathcart Fracture System (1990), cited by 1

Source page: https://510kreport.com/product-code/LZY
Data by year (CSV): https://510kreport.com/product-code/LZY.csv